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The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal angiography followed by renal sympathetic denervation | Experimental | Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic) |
|
| Renal angiography alone | Sham Comparator | Renal selective angiography using standardized method: Local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal angiography followed by renal sympathetic denervation | Procedure | Radiofrequency catheter based therapy for renal denervation: Symplicity catheter will be advanced into the renal artery and connected to a radiofrequency generator. As previously described, four-to-six discrete, low-power radio frequency treatments will be applied along the length of both main renal arteries. At least four radiofrequency applications will be delivered in each renal artery, unless this is not feasible for anatomical reasons. |
| Measure | Description | Time Frame |
|---|---|---|
| glomerular filtration rate | Isotopic and 24h urine sample measure of glomerular filtration rate. | 6 month |
| Ambulatory systolic and diastolic blood pressure | Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Baroreflex sensitivity | Migroneugraphy recording of sympathetic nerve activity and testing of baroreflex sensitivity | 6 month |
| Biological markers of acute kidney injury | Urine sample for NGAL, L-FABP and Cystatine C at baseline, H2, H6, 1, 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ARGACHA Jean francois, MD | Contact | 33225555214 | Jean.Francois.Argacha@erasme.ulb.ac.be |
| Name | Affiliation | Role |
|---|---|---|
| Jean-François ARGACHA, MD | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital | Recruiting | Brussels | 1070 | Belgium |
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|
| Renal angiography alone | Procedure | Procedure will start with a local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery, which allows a minimal risk of bleeding to the patient. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized. |
|
| baseline, H2, H6, 1, 3 and 6 months |